Regulatory Guide 4.15

Quality Assurance for Radiological Monitoring Programs (Normal Operations)-Effluent Streams and the Environment

ML13350A203
Person / Time
Issue date:	12/31/1977
From:	Office of Nuclear Regulatory Research
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RG-4.015
Download: ML13350A203 (10)

U.S. NUCLEAR REGULATORY COMMISSIONDecember 1977kREGULATORY GUIDEOFFICE OF STANDARDS DEVELOPMENTREGULATORY GUIDE 4.15QUALITY ASSURANCE FOR RADIOLOGICAL MONITORING PROGRAMS(NORMAL OPERATIONS)-EFFLUENT STREAMS AND THE ENVIRONMENT

A. INTRODUCTION

This guide describes a method acceptable to theNRC staff for designing a program to assure the qual-ity of the results of measurements of radioactive ma-terials in the effluents and the environment outside ofnuclear facilities during normal operations.Section 30.34. Terms and Conditions ofLicenses," of 10 CFR Part 30. "Rules of GeneralApplicability to Licensing of Byproduct Material."provides that the Commission mayý.incorporate in anybyproduct material license such'týrnis and conditionsas it deems appropriate or neccssary. in order to pro-ttr-t hn'ii,: ",T,The NRC regulations that require the control of re- Section 40.41. *.Terms".-nd Conditions ofleases of radioactive materials from nuclear facilities, Licenscs,' of I0.CFR'Part 402...Licensing ofSorcLicene -"Licesingof Sourcethat require the measurements of radioactive mate- Material," provides that'tihe Commission may incor-rials in the effluents and environment outside of these porate in any source material license such terms andfacilities, or that authorize license conditions not conditionsaasit d8ims appropriate or necessar) tootherwise authorized in the regulations are as protect heaih',follows: flSeW1i0 ws: 50o '"-Issuance of Licenses and Con-Section 20.106, "Radioactivity in Effluents to Un- ý,vucttor,1Permits," of 10 CFR Part 50, "Licensingrestricted Areas," of 10 CFR Part 20, "Standards for 'Iq production and Utilization Facilities." providesProtection Against Radiation." provides that a licen-r, t each operating license for a nuclear power plantsee shall not release to an unrestricted area radioac- ssued by the Nuclear Regulatory Commission willtire materials in concentrations that exceed , such conditions and limitations as the Com-.~ý; .." "is * .specified in 10 CFR Part 20 or as other%ýRe aui t -Mission deems appropriate and necessary.thorized in a license issued by the Comnssio Section 70.32, "Conditions of Licenses," of 10tion 20.201, "Surveys." of 10 CFR Pflýt fORti CFR Part 70. "Special Nuclear Material." providesrequires that a licensee conduct surv.ys, includingmeaurmetsofleel o raito or;' ... ..ton that the Commission may incorporate such terms andmeasurements of levels of radiation oroncentrations conditions as it deems appropriate or necessary toof radioactive materials, as necessary to i onstrate rotect health.compliance with the regulations in 10 CFR Part 20.Section IV.B. of Appendix i, "Numerical GuidesParagraph (c) of S4 n. /. "',Purpose," of 10 for Design Objectives and Limiting Conditions forCFR Part 20 states that r nable effort should Operation to Meet the Criterion 'As Low As Is Rea-be made by N P- se o maintain radiation ex- sonably Achievable' for Radioactive Material inposure, and f rdmoactive materials in Light-Water-Cooled Nuclear Power Reactoreffluents t a ricted reas, as far below the limits Effluents," to 10 CFR Part 50, "Licensing of Pro.-is reasonably achievable, tak- duction and Utilization Facilities," requires thating into " nt the state of technology and the eco- licensees establish an appropriate surveillance andnomics of " ' ovements in relation to public health monitoring program to provide data on quantities ofand safety an to the utilization of atomic energy in radioactive material released in liquid and gaseousthe public interest, effluents and to provide data on measurable levels ofUSNRC REGULATORY GUIDES Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, ReguRegulatory Guides are Issued to desctbe and make available to the public method0 1iotry Commission. Washington. D.C. 20555. Attention Dorheting i,,d Serviceacceplable to the NRC staff of implementing specific parts of the Commiusion's Brfanct .regulations, to delineate techniques used by the talfl in evaluating specific problems The guides are issued .n the tollow tnq ten broad d-%1.13or poltulated accidents, or to provide guidance to applicants. Regulatory Guidesare not tubssltult for regulations. and compliance with them is not required. 1. Power Reactors 6 ProtucltsMet',dt end solutions different from those set out in the guides will be accept. 2. Research and Test Reactors 7. Tans4tjrlit.tnable if they provide a basis for Ithe findings requisite to the issuance or continuance 3. Fuels and Materials Faclittes 8. Occuluational Healthof e permit or license by the Commli.son. 4. Enviros',,ental and Siting 9. Antitrust Rerty.v5. Materials and Plant Protection tO. GeneralComments and suggestions for improvements in thete guides ae encouraged at alltimes, and guides will be revisad. as apsrotortate. to accommodate comments and Requests Ifo single copies of issued (which mavy b. ertsL'Acovll at got elaceto reflect new informatiots or eaperierrce. cOmmlnts on this guide,if ment on an automatic dctlic'butlon list tO tirngle Coli.es el luture quidtr &it 'tieleci-ctaceived within about two months alter its jauance, will be partlcularly useful in should he mnde in writing to the US. Nuclear Regulatory Crmmoissot.evaluating the need lot an early revision, Washington. D.C. 20555. Attention. Directo,, Onvruon of DOcument Cunttol radiation and radioactive materials in the environ-ment. Section lll.B of Appendix I to 10 CFR Part 50provides certain effluent and environmental monitor-ing requirements. with respect to radioactive iodine ifestimates of exposure are made on the basis of exist-ing conditions and if potential changes in land andwater usage and food pathways could result in expo-sures in excess of the guidelines of Appendix I to 10CFR Part 50.General Design Criterion 60. "'Control of releasesof radioactive materials to the environment," of Ap-pendix A. "General Design Criteria for NuclearPower Plants." to 10 CFR Part 50 requires that nu-clear power plant designs provide means to controlsuitably the release of radioactive materials in gase-ous a:nd liquid effluents. General Design Criterion64. "Monitoring radioactivity releases." of Appen-dix A to 10 CFR Part 50 requires that nuclear powerplant designs provide means for monitoring effluentdischarge paths and the plant environs for radioactiv-ity that may be released from normal operations, in-cluding anticipated operational occurrences, and frompostulated accidents.General Design Criterion 1. "'Quality standardsand records." of Appendix A to 10 CFR Part 50 re-quires that a quality assurance program be establishedfor those structures, systems. and components of anuclear power plant that are important to safety inorder to provide adequate assurance that they willsatisfactorily perform their safety functions.Appendix B. "Quality Assurance Criteria for Nu-clear Power Plants and Fuel Reprocessing Plants," to10 CFR Part 50 establishes quality assurance re-quirements for the design, construction, and opera-tion of those structures, systems, and components ofthese facilities that prevent or mitigate the conse-quences of postulated accidents that could causeuridue risk to the health and safety of the pitblic. Thepertinent requirements of this Appendix apply to allsafety-related functions of these structures. systems,and components. This guide describes a method ac-ceptable to the NRC staff for the design and opera-tion of a program to meet the requirements of Ap-pendix B to 10 CFR Part 50, for the safety functionsof radiological monitoring of effluents and theenvironment.As used in the context of this guide. quality assur-ance comprises all those planned and systematic ac-tions that are necessary to provide adequate confi-dence in the results of a monitoring program, andquality control comprises those quality assurance ac-tions that provide a means to control and measure thecharacteristics of measurement equipment and proc-esses to established requirements; therefore, qualityassurance includes quality cot,,arol.The need for quality assurance is implicit in all re-quirements for effluent and environmental monitor-ing, and this need has been widely recognized. Regu-latory Guide 1.21, "Measuring, Evaluating, and Re-porting Radioactivity in Solid Wastes and Releases ofRadioactive Materials in Liquid and GaseousEffluents from Light-Water-Cooled Nuclear PowerPlants," Regulatory Guide 4.1. "Programs forMonitoring Radioactivity in the Environs of NuclearPower Plants:" Regulatory Guide 4,8. "Environmen-tal Technical Specifications for Nuclear PowerPlants;" and Regulatory Guide 4.14, "Measuring,Evaluating, and Reporting Radioactivity in Releasesof Radioactive Material in Liquid and AirborneEffluents from Uranium Mills," all give some guid-ance on means for assuring the quality of the meas-urements of radioactive materials in effluents and theenvironment outside of nuclear facilities. More com-plete and extensive guidance on this subject is pro-vided in this document for nuclear power reactorfacilities and for other facilities for which radiologi-cal monitoring is required by the NRC. This guidanceapplies both to monitoring that is safety-related andmonitoring that is not. For safety-related monitoringof nuclear power plants and fuel reprocessing plants,other regulatory guides on quality assurance (in theDivision I and the Division 3 series of regulatoryguides) should be consulted to determine theirapplicability, if any. to the radiological monitoringactivities.

B. DISCUSSION

• To assure that radiological monitoring meas-urements are reasonably valid, organizations per-forming these measurements have found it necessaryto establish quality assurance programs. These pro-grams are needed for the following reasons: (1) toidentify deficiencies in the sampling and measure-ment processes to those responsible for these opera-tions so that corrective action can be taken, (2) toprovide a means of relating the results of a particularmonitoring program to the National Bureau of Stand-ards and thereby to provide a common basis for com-paring the results of various programs, and (3) to ob-tain some measure of confidence in the results of themonitoring programs in order to assure the regulatoryagencies and the public that the results are valid.Existing published guidance on specific quality as-surance actions which are applicable to radiologicalmonitoring is limited and, in general, is restricted toquality control practices for radioanalytical labora.tories (Refs. 1-3). However, quality assurance shouldbe applied to all steps of the monitoring process thatmay include sampling, shipment of samples, receiptof samples in the laboratory, preparation of samples,measurement of radioactivity (counting), data reduc-tion, data evaluation, and reporting of the monitoringresults.*Definitions of special terms used in this guide are given in aglossary in Appendix A.4.15-2 The scope of this guide is limited to the elementsof a quality assurance program, which is a planned.systematic, and documented program that includesquality control. Guidance on principles and goodpractice in the monitoring process itself and guidanceon activities that can affect the quality of the monitor-ing results (e.g., design of facilities and equipment)are outside the scope of this guide. However, somereferences are provided to documents that do providesome guidance in these areas. The citation of thesereferences does not constitute an endorsement of allof the guidance in these documents by the NRC staff.Rather, these references are provided as sources ofinformation to aid the licensee and the licensee's con-tractors in developing and maintaining a monitoringprogram.Every organization actually performing effluentand environmental monitoring, whether an NRClicensee or the licensee's contractor, should includethe quality assurance program elements presented inthis guide.

C. REGULATORY POSITION

The quality assurance program of each organiza-tion performing effluent or environmental monitoringof nuclear facilities for normal operations should bedocumented by written policies and procedures andrecords. These documents should include the ele-ments given in this section.In addition to its own program, a licensee shouldrequire any contractor or subcontractor performingmonitoring activities for the licensee to provide aquality assurance program consistent with the provi-sions of this guide, as follows:1. Organizational Structure and Responsibilitiesof Managerial and Operational PersonnelThe structure of the organization as it relates to themanagement and operation of the monitoring pro.gram(s), including quality assurance policy and func-tions, should be presented. The authorities, duties,and responsibilities of the persons holding specifiedpositions within this organization should be stated,including responsibilities for review and approval ofwritten procedures and for preparation, review, andevaluation of monitoring data and reports.Persons and organizations performing quality as-surance functions should have sufficient authorityand organizational freedom to identify quality prob-lems; to initiate, recommend, or provide solutions;and to verify implementation of solutions.2. Specification of Qualifications of PersonnelThe qualification of. individuals performingradiological monitoring to perform their assignedfunctions should be specified and documented. Speci.fication of these qualifications in terms of previoustraining and performance on the job or satisfactorycompletion of proficiency testing is prclerred to spec-ification of education and experience levels.An introduction and orientation program, appro-priate to the size and complexity of the organization.should provide that (a) personnel performingquality-related activities are trained and qualified inthe principles and techniques of the activities per-formed. and (b) proficiency of personnel who per-form activities affecting quality is maintained by re-training, reexamining. and recertifying. as appropriateto the activity performed.3. Operating Procedures and InstructionsWritten procedures should be prepared. reviewed.and approved for activities involved in carrying outthe monitoring program. including sample collection:packaging. shipment. and receipt of samples foroffsite analysis: preparation and analysis of samples:maintenance, storage. and use of radioactive refer-ence standards; calibration and checks of radiationand radioactivity measurement systems: and reduc-tion. evaluation, and reporting of data. Individualswho review and approve these procedures should beknowledgeable in the subjects of the procedures.Guidance on principles and good practice in manyof these activities is presented in NRC regulatoryguides (Refs.4-7) and other publications (Refs. 2.3.8-25). In addition to these publications, the AmericanPublic Health Association is preparing a book onquality assurance practices in health laboratories thatwill include a chapter on radiochemistry. and Scien-tific Committee 18A of the NCRP is preparing amanual of radioactivity measurement procedures thatwill be a revision of NCRP Report 28, NBS Hand-book 80, "'A Manual of Radioactivity Procedures."4. RecordsThe records necessary to document the activitiesperformed in the monitoring program should be spec-ified in the quality assurance program.One key aspect of quality control is maintainingthe ability to track and control a sample in its prog-ress through the sequence of monitoring processes.4.15-3 Records to accomplish this should cover the follow-* ing proce.sses: field and inplant sample collection andsample description; sample receipt and laboratoryidentification coding, sample preparation and* radiochcmical processing (e.g., laboratory note-books); radioactivity measurements (counting) of* samples, instrument backgrounds. and analyticalblanks. and data reduction and verification.Quality control records for laboratory counting sys-tems should include the results of measurements ofradioactive check sources, calibration sources, back-grounds. and blanks.Records relating to overall laboratory performanceshould include the results of analysis of quality con-trol samples such as analytical blanks, duplicates,interlaboratory cross-check samples and other qualitycontrol analyses; use of standard (radioactive) refer-ence materials to prepare working standards; prepara-tion and standardization of carrier solutions; andcalibration of analytical balances.Additional records that are needed should includethe calibration of inline radiation detection equip-ment. air samplers, and thermoluminescencedosimetry systems; verification and documentation ofcomputer programs; qualifications of personnel; andresults of. audits.The minimum period of retention of the recordsshould be specified. Only the final results of themonitoring programs need be retained for the life ofthe facility.5. Quality Control in Sampling (Including Packag-Ing, Shipping, and Storage of Samples)Continuous sampling of liquids and gases involvesthe measurement of sample flow rates and/or samplevolumcs. The accuracy of the devices used for thispurpose should be determined on a regularly sched-uled basis, and adjustments should be made asneeded to bring the performance of the devices withinspecified limits. The results of these calibrationsshould be recorded. The frequency of these calibra-tions should be specified and should be based on therequired accuracy, purpose, degree of usage, stabilitycharacteristics, and other conditions affecting the* measurement. Continuous sampling should be dem-onstrably representative of the material volumes sam-pled. The collection efficiencies of the samplers usedshould be documented.Grab samples should be demonstrably representa-tive of the material sampled, and replicate samplesshould be taken periodically to demonstrate the re-producibility of sampling.Procedures for sampling, packaging, shipping, andstorage of samples should be designed to maintair (l;!:integrity of the sample from time of collection t, timcof analysis. Aqueous samples may present a particu-lar problem in this regard, and one of the most severeproblems has been encountered with aqueous samplesof radioactive wastes from operating nuclear reactors(Ref. 2 ).Guidance on the principles and practice of sam-pling in environmental monitoring is provided in sev-eral publications (Refs. 2,9.19). In addition, workersat the National Bureau of Standards (NBS) have pub-lished the results of a survey of information on sam-pling, sample handling, and long-term storage forenvironmental materials (Ref. 13). Some guidance onthe principles and practice of air sampling is providedin References 15, 17, and 22. Guidance on the prin-ciples and practice of water sampling is provided innumerous publications (Refs. II, 12, 23-25).6. Quality Control in the Radioanalytical Labora-tory6.1 Radionuclide Reference Standards-Use forCalibration of Radiation MeasuretnenitSystemnsReference standards are used to determine countingefficiencies for specific radionuclides or, in the caseof gamma-ray spectrometry systems, to determinecounting efficiency as a function of gamma-rayenergy. A counting efficiency value is used to con-vert a sample counting rate to the disintegration rateof a radionuclide or to a radionuclide concentration.(Guidance on calibration and usage of germanium de-tectors for measurement of gamma-ray emission ratesof radionuclides is being prepared by a writing groupof the Health Physics Society Standards Committeefor publication as an ANSI Standard.)Radionuclide standards that have been certified bythe NBS, or standards that have been standardizedusing a measurement system that is traceable to thatof the NBS,* should be used when such standards are*For a discussion by NBS staff members of the concept oftraceability of radioactivity measurements to NBS, see Refer-ence 27.A brief summary of this discussion is as follows: Thereare both direct and indirect traceability. Direct traceability toNBS exists when. any outside laboratory prepares a batch ofcalibrated radioactivity standards and submits several randomlyselected samples to NBS for confirmation or verification. Indi.rect traceability to NBS exists when NBS provides "unknown"calibrate radioactivity samples to one or more laboratories whichin turn make measurements of activity that agree within certainspecified limits with those of NBS. Thus there can be 1%, etc.,traceability. Regular use of NBS radioactivity standards by anoutside laboratory to calibrate its measuring equipment does not,in the view of the NBS staff, constitute traceability. Only whenthe outside laboratory can measure the activity of an unknownsample and send back values to NBS that agree with NBS valueswithin a certain specified range of error does NBS consider thattraceability has been established. NBS notes that this conditioncan be achieved without using a single NBS standard.4.15-4 available. Otherwise, standards should be obtainedfrom other reputable suppliers. An "International Di-rectory of Certified Radioactive Materials" has beenpubli.;hcd by the International Atomic EnergyAgency (Ref. 26).Acceptable standards for certain natural radionuc-lides may be prepared from commercially availablehigh-purity chemicals. For example, potassium-40standards for gross beta measurements or gamma-rayspectrometry may be prepared from dried reagent-grade potassium chloride.The details of the preparation of working standardsfrom certified standard solutions should be recorded.The working standard should be prepared in the sameform as the unknown samples, or close approxima-tion thereto.Efficiency calibrations should he checked periodi-cally (typically monthly tc yearly) with standardsources. In addition, these checks should be madewhenever the need is indicated, such as when a sig-nificant change in the measurement system is de-tected by routine measurements with a check source.6.2 Performance Checks of Radiation Measure-Inenit SystemsDetermination of the background counting rate andthe response of each radiation detection system to ap-propriate check sources should be performed on ascheduled basis for systems in routine use. The re-sults of these measurements should be recorded in alog and/or plotted on a control chart. Appropriate in-vestigative and corrective action should be takenwhen the measurement value falls outside the pre-determined control value.A check source for determining changes in count-ing rate or counting efficiency should be of sufficientradiochemical purity to allow correction for decay butneed not have an accurately known disintegrationrate, i.e., need not be a standard source.For systems in which samples are changed manu-ally, check sources are usually measured daily. Forsystems with automatic sample changers, it may bemore convenient to include the check source withineach batch of samples and thus obtain a measurementof this source within each counting cycle. For propor-tional counter systems, the plateau(s) should bechecked after each gas change. Background meas-urements should be made frequently to ensure thatlevels arc within the expected range. For systemswith automatic sample changers, background mncas-urements should be included within each countingcycle.For alpha- and gamma-ray spectrometry systems,energy-calibration sources (i.e.. a source containing aradionuclide. or mixture of radionuclides. emittingtwo or more alpha or gamma rays of known energies)arc counted to determine the relationship betweenchannel number and alpha- or gamma-ray energy.The frequency of these energy calibration checks de-pends on the stability of the system but usually is inthe range of daily to weekly. The results of theseshould be recorded and compared topredetermined limits in order to determine whether ornoi system gain and zero level need adjustment. Ad-justmients should be made as necessary.Additional checks needed for spectrometry systemsare the energy resolution of the system and the countrate (or counting efficiency) of a check source. Theseshould be determined periodically (usually weekly tonmonthly for energy resolution and daily to weekly forcount rate) and after system changes, such as powerfailures or repairs, to determine if there has been anysignificant change in the system. The results of thesemeasurements should be recorded.6.3 Analysis of Quality' Control SamplesThe analysis of quality control samples provides ameans to determine the precision and accuracy of themonitoring processes and include!, both intralabora-tory and interlaboratory measurements.The analysis of replicate samples provides a meansto determine precision: the analysis of samples con-taining known concentrations of radionuclides pro-vides a means to deter'mine accuracy. The analysis oflaboratory blanks provides a means to detect andmeasure radioactive contamination of analytical sam-ples, a common source of error in radiochemicalanalysis of low-level samples. The analysis of analyt-ical blanks also provides information on the adequacyof background subtraction, particularly for samplesmeasured by gamma-ray spectrometry.The fraction of the analytical effort needed for theanalysis of quality control samples depends to a largeextent on (I) the mixture of sample types in a particu-lar laboratory in a particular time period and (2) thehistory of performance of that laboratory in the anal-ysis of quality control samples. H6wever, in generalit is found that at least 5%, and typically 10%, of theanalytical load should consist of quality controlsamples.4.15-5 6.3.1 Intralaboratory AnalysesReplicate samples, usually duplicates, should beanalyzed routinely. These replicates should be pre-pared from samples that are as homogeneous as pos-sible, such as well-stirred or mixed liquids (water ormilk) and solids (dried, ground, or screened soil, sed-iment, or vegetation; or the ash of these materials).The size and other physical and chemical characteris-tics of the replicate samples should be similar tothose of single samples analyzed routinely.The analysis of the replicate samples as blind re-plicates is desirable but is not practicable for all lab-oratories or for all types of samples. For example, insmall laboratories it may not be practicable to preventthe analysts from being aware that particular samplesare replicates of one another.Obtaining true replicates of all types .of samplesalso is not practicable. For example, obtaining repli-cate samples of airborne materials usually is not prac-ticable on a routine basis because it requires either aseparate sampling system or splitting a single sample(e.g., cutting a filter in half). Use of replicatesamplers usually is not economically feasible andsplitting of samples results in replicates that do notrepresent the usual sample size or measurement con-figuration (counting geometry) for direct measure-ment. However, simulated samples of airborne mate-rials may be prepared in replicate and submitted foranalysis as unknowns.Analysis of intralaboratory blank and spiked sam-ples is an important part of each laboratory's qualitycontrol program. A known analytical blank sampleshould be analyzed with each group of unknownsamples that is processed radiochemically to deter-mine a specific radionuclide or radionuclides. Spikedand blank samples should be submitted for analysisas unknowns to provide an intralaboratory basis forestimating the accuracy of the analytical results.These blanks and spikes may include blind replicates.6.3.2 Interlaboratvry AnalysesAnalysis of effluent and environmental samplessplit with one or more independent laboratories is animportant part of the quality assurance program be-cause it provides a means to detect errors that mightnot be detected by intralaboratory measurementsalone. When possible, these independent laboratoriesshould be those whose measurements are traceable toNBS (Ref. 27).Analysis of split field samples, such as samples ofmilk, water, soil or sediment, and vegetation, is par-ticularly important in environmental monitoring pro-grams to provide an independent test of the ability tomeasure radionuclides at the very low concentrationspresent in most environmental samples.The NRC Office of Inspection and Enforcementconducts a Ccnfirmatory Measurements Program forlaboratories of licensees that measure nuclear reactoreffluents. The analyses of liquid waste holdup tanksamples, gas samples, charcoal cartridges, and stackparticulate filters are included in this program. Theresults of the licensee's measurements of samplessplit with the NRC are compared to those of an NRCreference laboratory whose measurements are trace-able to the National Bureau of Standards (Ref. 27).Thus the results of this comparison provide to theNRC an objective measure of the accuracy of thelicensee's analyses.Laboratories of licensees or their contractors thatperform environmental measurements should partici-pate in the EPA's Environmental Radioactivity Lab-oratory Intercomparison Studies (Cross-check) Pro-gram, or an equivalent program. This participationshould include all of the determinations (samplemedium/radionuclide combinations) that are both of-fered by EPA and included in the licensee's environ-mental monitoring program. Participation in the EPAprogram provides an objective measure of the accu-racy of the analyses because the EPA measurementsare traceable to the National Bureau of Standards. Ifthe mean result of a cross-check analysis exceeds thecontrol limit as defined by EPA (Ref. 28), an investi-gation should be made to determine the reason forthis deviation and corrective action should be takenas necessary. Similarly, an investigation and anynecessary corrective action should take place if the"normalized range." as calculated by EPA, exceedsthe control limit, as defined by EPA. A series of re-sults that is within the control limits but that exhibitsa trend toward these limits may indicate a need for aninvestigation to determine the reason for the trend.6.4 Compuitational ChecksProcedures for the computation of the concentra-tion of radioactive materials should include the inde-pendent verification of a substantial fraction of theresults of the computation by a person other than theone performing the original computat'on. For com-puter calculations, the input data should be verifiedby a knowledgeable individual. All computer pro-grams should be documented and verified before ini-tial routine use and after each modification of theprogram. The verification process should include ver-ification, by a knowledgeable individual, of the al-gorithm used and test runs in which the output of thecomputer computation for given input can be com-pared to "true" values that are known or determined4.15-6 independently of the computer calculation. Documen-tation of the program should include a description ofthe algorithm and a current listing of the program.Guidelines for the documentation of digital computerprograms are given in ANSI N413-1974 (Ref. 29).7. Quality Control for Continuous EffluentMonitoring SystemsThe specified frequency of calibration for a par-ticular system should he based on considerations of thenature and stability of that system. For nuclear powerplants, specific requirements for calibrations andchecks of particular effluent monitoring systems usu-ally are included in the technical specifications forthe plant.Initial calibration of each measuring system shouldbe performed using one or more of the referencestandards that are certified by the National Bureau ofStandards or that are calibrated by a measurementsystem that is traceable to that of the National Bureauof Standards (Ref. 27). For nuclear power plants,these calibrations are usually repeated at least annu-ally. The radionuclide standards should permit calib-rating the system over its intended range of energyand rate capabilities. Periodic inplant calibrationshould be performed using a secondary source ormethod that has been related to the initial calibration.For nuclear power plants, these calibrations are usu-ally performed at least monthly.Periodic correlations should be made during opera-tion to relate monitor readings to the concentrationsand/or release rates of radioactive material in themonitored release path. These correlations should bebased on the results of analyses for specific radionuc-lides in grab samples from the release path.Flow-rate measuring devices associated with thesystem should be calibrated to determine actual flowrates at the conditions of temperature and pressureunder which the system will be optrated. These flowrate devices should be recalibrated periodically.Whenever practicable, a check source that is ac-tuated remotely should be installed for integritycheeks of the detector and the associated electricalsystem.8. Review, Analysis, and Reporting DataProcedures for review, analysis, and reporting ofdata should include examinatiuns for reasonablenessand consistency of the data and investigative andcorrective actions to be taken under specifiedcircumstances.9. AuditsPlanned and periodic audits should be made to ver-ify implementation of the quality assurance program.The audits should be performed by qualified indi-viduals who do not have direct responsibilities in theareas being audited.Audit results should be documented and reviewedby management having responsibility in the area au-dited. Followup action, including reaudit of deficientareas, should be taken where indicated.

D. IMPLEMENTATION

The purpose of this section is to provide informa-tion to applicants and licensees regarding the NRCstaff's plans for using this regulatory guide.This guide reflects current NRC staff practice.Therefore, except in those cases in which the appli-cant or licensee proposes an acceptable alternativemethod, the staff will use the method describedherein in evaluating an applicant's or licensee's ca-pability for and performance in complying with spec-ified portions of the Commission's regulations untilthis guide is revised as a result of suggestions fromthe public or additional staff review.4.15-7 REFERENCESI. Section 6.2, "Validation of Analyses," Chapter6, "Validity of Results," Methods of RadiochewnicalAnalysis, World l-ealth Organization, Geneva, 1966.2. "Analytical Quality Control Methods," Environ-mental Radioactivity Surveillance Guide, U.S. En-vironniental Protection Agency Report, ORP/SID72-2, June 1972.3. Environmental Ra,.'iation Measurements, Reportof NCRP SC.35, NCRP Report No. 50, 1976.4. Regulatory Guide 1.21, "Measuring, Evaluating,and Reporting Radioactivity in Solid Wastes and Re-leases of Radioactive Materials in Liquid and Gase-ous Effluents from Light-Water-Cooled NuclearPower Plants."5. Regulatory Guide 4.5, "Measurements ofRadionuclides in the Environment-Sampling andAnalyses of Plutonium in Soil."6. Regulatory Guide 4.6, "Measurements ofRadionuclides in the Environment-Strontium-89 andStrontium-90 Analyses."7. Regulatory Cuide 4.13, "Performance, Testing,and Procedural Specifications for Thermolumines-cence Dosimetry: Environmental Applications."8. HASL Procedures Manual, U.S. Energy Researchand Development Administration Report, HASL-300,1972 (updated annually).9. A Guide for Environmental Radiological Surveil-lance at ERDA Installations, Energy Research andDevelopment Administration Report, ERDA 77-24,March 1977.10. Handbook of Radiochemical Analytical Methods,U.S. Environmental Protection Agency Report,EPA-680/4-75-001, February 1975.I1. Standard Methods for the Examination of Waterand Wastewater, Thirteenth Edition, American Pub-lic Health Association, 1975.12. Handbook for Sampling and Sample Preservationof Water and Wastewater, U.S. Environmental Pro-tection Agency Report, Office of Research and De-velopment, Environmental Monitoring Support Lab-oratory, EPA-200/4-76-049. September 1976i13. E. J. Maienthal and D. A. Becker, "A Survey onCurrent Literature on Sampling, Sample Handling,and Long-Term Storage for Environmental Materials,"Interface 5 (#4), 49-62 (1976). Also available fromthe Superintendent of Documents, U.S. GovernmentPrinting Office, Washington, D.C. 20402, as NBSTechnical Note #929, October 1976, C 13.46:929,S/N 003.003-01694-2.14. Tritium Measure.'ent Techniques, Report ofNCRP SC-36, NCRP Report No. 47, 1976.15. "Guide to Sampling Airborne Radioactive Mate-rials in Nuclear Facilities," ANSI N 13.1-1969.16. "Specification and Performance of On-Site In-strumentation for Continuously Monitoring Radioac-tivity in Effluents," ANSI N13.10-1974.17. Air Sampling Instruments for Evaluation of At-mospheric Contaminants, Fourth Edition, AmericanConference of Industrial Hygienists, 1972.18. Users' Guide for Radioactivity Standards. Sub-committee on Radiochemistry and Subcommittee onthe Use of Radioactivity Standards, Committee onNuclear Science, National Academy of Sciences-National Research Council Report, NAS-NS-3115,February 1974.19. Environmental Impact Monitoring for NuclearPower Plants, Source Book of Monitoring Methods,Vol. I, Atomic Industrial Forum Report, AIF/NESP-004, February 1975.20. Instrumentation for Environmental Monitoring:Radiation, Lawrence Berkeley Laboratory Report,LBL-l, Vol. 3, First Ed., May 1972; First update,February 1973; Second update, October 1973.21. C. W. Sill, "Problems in Sample Treatment inTrace Analysis." National Bureau of Standards Spe-cial Publication 4-22, Accuracy in Trace Analysis:Sampling, Sample Handling. and Analysis, pp. 463-490, August 1976.22. "General Principles for Sampling AirborneRadioactive Materials," International Standard,ISO-2889, 1975.23. Manual of Methods for Chemical Analysis ofWater and Wastes, EPA-625/6-74-003, U.S. En-vironmental Protection Agency, Office of Technol-ogy Transfer, Washington, D.C. 20460, 1974.24. Annual Book of ASTM Standards (Part 31), Wa-ter, American Society for Testing and Materials,Method D, 3370, pp. 71-82, Philadelphia, PA, July1975.4.15-8 25. Biological Field and Laboratory, Methods forMeasuring the Quality of Surface Waters andEffluents, EPA-670/4-73-001, Office of Research andDevelopment, U.S. Environmental ProtectionAgency, Cincinnati, Ohio, July 1973.26. International Directory of Certified RadioactiveMaterials, International Atomic Energy Agency Re-port, STI/PUB/398, 1975.27. L. M. Cavallo et al.. "Needs for RadioactivityStandards and Measurements in Different Fields,"Nuclear Instruments and Methods, Vol. 112, pp.5-18, 1973.28. Environmental Radioactivity Laboratory Inter-comparison Studies Program, FY 1977, EPA-600/4.77-001, January 1977.29. "Guidelines for the Documentation of DigitalComputer Programs," ANSI N413- 1974.4.15-9 APPENDIX AGLOSSARYA-ccurac'yv-normally refers to the difference (error orbias) between tile mean, K. of the set of results andthe value *. which is accepted as the true or correctvalue for the quantity measured. It is also used as thedifference between an individual value X, and X.Absolhte acciuracy of the mean is given by and of an individual value by XrT.Relative accrwvr of the mean is given by t.-,)/:.Pr'rcentage is given by 100 ,Imd Blank (Sample) -ideally. a sample havingall of the constituents of the unknown sample exceptthose to be determined. In radioanalytical practice.the term often refers it) the radiochemical processingof carrier(s) or tracers without the sample matrix ma-terial."Blind" Replivcat (Sample)-replicate samples thatare not identified as replicates to the persons pcrform-ing the analysis.Calibrainon-the process of determining the numeri-cal relationship between the observed output of ameasurement system and the value, based on refer-ence standards, of the characteristics being measured.Calibration Source-any radioactive source that isused for calibration of a measurement system.Check Source (or instrumnent check source, perform-anlce check source, or referJence source)-a radioac-tive source used to determine if the detector and allelectronic components of the system are operatingcorrectly.Instrument Batckground--the response of the instru-ment in the absence of a radioactive sample or otherradioactive source.Precision-relates to the reproducibility (f meas-urements within a set, that is. to the scatter or disper-son of a set about its central value.Quality Assurance (QA )-(the planned and systematicactions that are necessary to provide adequate confi-dence in the results of a monitoring program.Quaitiy Control (QC)-those quality assurance ac-tions that provide a means to control and measure thecharacteristics of measurement equipment and proc-esses to established requirements. Thus. quality as-surance includes quality control.Spiketd Sample-a sample to which a known amountof radioactive material has been added. Generally.spiked samples are submitted as unknowns to theanalysts.Split Sample-a sample that is divided into parts.each of which is analyzed independently by separatelaboratory organizations.Standard (radioactive) Source-a radioactive sourcehaving an accurately known radionuclide content andradioactive disintegration rate or particle or photonemission rate.4.15-10